FDA applicant
Icl Scientific
FDA records 48 decisions for Icl Scientific (Mchenry, IL) from 1976 to 1988: 48 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and JJW (Urinalysis Controls (Assayed And Unassayed)). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Icl Scientific’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Icl Scientific since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Icl Scientific’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report